Frequently Asked Questions
The “Patients’ Access to Treatments Act of 2013” – H.R. 460
Who supports the Patients’ Access to Treatments Act?
The bipartisan Act (H.R. 460) has support from Republicans and Democrats in Congress and is endorsed by
physician
andMelnick,
patient Arthritis
organizations
including
the American
Academy
of Pediatrics,
Academy of
Contact: Amy
Foundation
Vice President
for Advocacy,
(202)
887-2910 orAmerican
amelnick@arthritis.org
Neurology, American Autoimmune Related Diseases Association, American College of Rheumatology, American
Society of Clinical Oncology, Arthritis Foundation, Colon Cancer Alliance, Crohn's and Colitis Foundation of
America, GBS/CIDP Foundation International, Hemophilia Federation of America, Immune Deficiency
Foundation, Leukemia & Lymphoma Society, Lupus Foundation of America, National Hemophilia Foundation,
National Patient Advocate Foundation, National Psoriasis Foundation, Oncology Nursing Society, Patient
Services Incorporated, Pulmonary Hypertension Association, Sjögren's Syndrome Foundation, Spondylitis
Association of America, The Alliance for Patient Advocacy, and the US Hereditary Angioedema Association.
Why should we support the “Patients’ Access to Treatments Act”?
Traditionally, commercial health insurers have charged patients fixed co-pays for different tiers of medications:
generics (Tier I), name brands (Tier II), and off formulary “non-preferred” brand medications (Tier III). As an
example, the co-pays might be set at $10/$20/$50 for the three tiers.
Some health insurance policies are now moving necessary medications (mostly biologics) into “specialty tiers”
that utilize high patient cost-sharing methods. The specialty tiers (Tier IV and higher) commonly require patients
to pay a percentage of the actual cost of these drugs – from 25% to 33% or more, often costing hundreds of
dollars, even thousands of dollars, per month for a single medication – rather than a fixed, flat dollar co-payment.
These practices are placing medically-necessary treatments out of reach of average insured Americans. They
will also lead to increased rates of disability and rising health care costs as more patients forego treatment.
What will the legislation do?
The bipartisan House version of this legislation, the Patients’ Access to Treatments Act of 2013 (H.R. 460),
introduced by Rep. McKinley (R-WV), would restrain high cost-sharing for specialty medications, thereby
enabling more patients with chronic, disabling, and life threatening conditions to access the treatments they
need. It would limit cost-sharing requirements applicable to medications in a specialty drug tier (typically Tier IV
or higher) to the dollar amount applicable to drugs in a non-preferred brand drug tier (typically Tier III). It will
enable patient access to treatments, reduce disability and constrain health care costs.
Who would be helped by this Act?
The Patients’ Access to Treatments Act would help patients with chronic, life-threatening, and disabling
conditions who require so-called “specialty” drugs, which are mostly biologic treatments. These biologic
medicines have no generic or inexpensive equivalents. Affected patients include those certain types of cancer
like leukemia and lymphoma, multiple sclerosis, rheumatoid arthritis, psoriatic arthritis, lupus, primary
immunodeficiency diseases, hemophilia, Crohn’s disease, and other conditions. Patients who currently
endanger their health by having to skip doses or go without treatment altogether due to excessively high costsharing would be helped by the limitations put in place by the Act.
Would the Act affect employer-based self-insured plans?
In addition to assisting individuals with chronic conditions who purchase commercial health plans, the Act would
allow greater treatment access for individuals who have coverage through their employers’ self-funded health
plans, which are governed by the Employee Retirement Income Security Act. While bills in state legislatures
cannot address employer self-insured plans governed by ERISA, the Patient’s Access to Treatments Act would
amend Title XXVII of the Public Health Service Act. PATA is consistent with other amendments to this Title that
have been found to clearly apply to self-insured plans. Direct amendments to ERISA are not necessary.
What about Medicare beneficiaries?
This Act would not address specialty tiers in Medicare part D programs, and additional legislation would be
needed to limit the excessive cost sharing of specialty tiers for Medicare beneficiaries. There is legislation in the
current Congress that would provide an appeals and exceptions process for Medicare beneficiaries who have
had their treatments placed in a specialty tier with high cost-sharing. Many of the conditions treated by biologic
medicines hit individuals in the prime of their lives as adults – or even as children. The population that needs
protection from specialty tier barriers to treatment is much broader than just Medicare beneficiaries.
Will the Act increase the cost of insurance? If cost sharing for high-cost medicines is limited, who
would shoulder the burden of these costs?
The purpose of health insurance is to spread risk and share health care costs. Specialty tiers do the opposite by
passing on the financial burden to the patient with a chronic condition, while healthy patients and the insurance
company pay less. It is not appropriate for medically-necessary treatments for some conditions to be singled out
for co-insurance so excessive that the insured patients cannot afford the treatments they need.
It is likely that as health insurance companies adjust cost-sharing in response to the need to avoid these serious
problems with patient access, they will spread the risk and costs among the entire pool of insureds. Because a
limited number of people need specialty medications, increases in premiums for the group should be minimal.
What if insurance companies increase cost sharing for Tier III non-preferred brand drugs, rather
than spread the cost among the premiums of the entire pool of insureds?
It is possible that insurance companies could choose to increase cost-sharing requirements for non-preferred
brand drugs in plans (typically Tier III), rather than spread costs through premiums. Tier III drugs typically have
co-payments of $30 to $50, which is much more affordable than specialty tier coinsurance of $600, $800 or more
per drug per month.
We do not have reason to believe that increases in non-preferred brand drug co-payments would be excessive.
But insurance companies should note that researchers have found consumers are willing to pay a slightly higher
premium if an insurance plan provides for affordable cost-sharing for these specialty drugs. High cost-sharing for
specialty drugs, rather spreading costs through premiums, runs counter to what most consumers prefer.
Won’t the federal health care law make these protections for chronically-ill patients unnecessary?
Provisions of the Affordable Care Act would cap total yearly out-of-pocket costs at around $6,000 for individuals
and $12,000 for families. Even with these caps in place, many patients’ out-of-pocket expenses could easily
exceed their threshold to pay and thereby limit access to critically-needed treatments. The caps also do not take
effect until 2014, and patients facing disability, serious illness or death because of their illnesses cannot wait for
this very limited relief.
Isn’t the problem the high cost of biologic drugs? Shouldn’t the high cost be addressed by the
drug manufacturers?
What makes biologics so expensive is the materials required to create them, complex manufacturing processes
using live organisms, and the high cost of development. Currently there are no generic or biosimilar alternatives
for these treatments. Biologics that treat a condition in one patient may not work for others. A path for biosimilars
is years away and it will be difficult to ensure medications are replicated safely and effectively. The FDA is
working to implement the Biologics Price Competition and Innovation Act of 2009, establishing an abbreviated
approval path for biologics demonstrated as “highly similar” to, or “interchangeable” with, FDA-licensed biologics.
Patients have been dealing with expensive drugs for years, but most have been able to access the treatments
they need until the creation of specialty tiering and excessive cost-sharing. The Patients’ Access to Treatments
Act is one way to limit the cost-sharing burden so that patients of average means can access the treatments they
need to avoid disability, seriously illness, or death. Additionally, increased availability of co-pay assistance from
drug companies would effectively lower the cost of these treatments. Currently pharmaceutical companies are
prohibited from providing direct co-pay assistance to Medicare beneficiaries as they do for other patients. We
also welcome efforts by the pharmaceutical industry to lower costs of these critical therapies.
Don’t biologic medicines have Patient Assistance Programs that address these access issues?
Patient Assistance Programs offered by foundations and pharmaceutical companies provide much-needed
assistance to patients who have difficulty paying the cost-sharing required for their treatments. The problem is
that the assistance provided by pharmaceutical foundations is limited, and the dollars available often run out
before eligible patients can receive assistance. These charitable foundations also typically impose income
requirements that exclude many patients in need. Drug companies are currently prohibited from providing direct
cost-sharing assistance to many patients including Medicare, Tricare, and other beneficiaries.